Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107601
Status:
COMPLETED
Last Update Posted:
2008-06-27
First Post:
2005-04-05
Brief Title:
Glucontrol Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Sponsor:
University of Liege
Organization:
University of Liege
Study Overview
Official Title:
A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glucontrol is a prospective randomized controlled multi-centric study The present study will compare the effects of two regimens of insulin therapy respectively titrated to achieve a blood sugar level between 44 and 61 mmoll 80 and 110 mgdl respectively and between 78 and 100 mmoll 140 and 180 mgdl respectively
This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients around 3000 patients
Secondary outcome variables will include in-hospital and 28-day mortality lengths of stays in the Intensive Care Unit ICU and in the hospital length of ICU stay without life-support therapy number and clinical signs of episodes of hypoglycemia rates of infections and organ failures and number of red-cell transfusions
This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients around 3000 patients
Secondary outcome variables will include in-hospital and 28-day mortality lengths of stays in the Intensive Care Unit ICU and in the hospital length of ICU stay without life-support therapy number and clinical signs of episodes of hypoglycemia rates of infections and organ failures and number of red-cell transfusions
Detailed Description:
Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious vascular and metabolic complications We hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients This hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia However these findings can hardly be extrapolated to other conditions including different types of pathologies and management The present prospective randomized controlled and multicentric study will compare the effects of two regimens of insulin therapy respectively titrated to achieve a blood sugar level between 44 and 61 mmoll 80 and 110 mgdl respectively and between 78 and 100 mmoll 140 and 180 mgdl respectively and will be powered to detect a 4 decrease in absolute intensive care unit ICU mortality Secondary outcome variables will include in-hospital and 28-day mortality lengths of stays in ICU and in the hospital length of ICU stay without life-support therapy number and clinical signs of episodes of hypoglycemia rates of infections and organ failures number of red-cell transfusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT Number 200400391440 | None | None | None |